510(k) Report

Devices descending from K031455

179 later devices reach Conklusion Pedicle Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070933Lowtop Pedicle Screw SystemSanacor2007178—
+2K080504Pioneer Lowtop Spinal Rod SystemPioneer Surgical Technology200892—
+2K072187Pioneer Lowtop Spinal Rod SystemPioneer Surgical Technology2007177—
+3K093692Quantum/ Streamline Spinal System Model 02-Series and 10-SeriesPioneer Surgical Technology201090—
+3K093771Quantum/Streamline TL Mis Spinal SystemPioneer Surgical Technology20108—
+3K080518Pioneer Surgical Technology Quantum Spinal SystemPioneer Surgical Technology2008174—
+3K080026Quantum-Mis Cannulated SystemPioneer Surgical Technology200812—
+4K130286Streamline Mis Spinal Fixation SystemPioneer Surgical Technology, Inc.201371
+4K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+4K110692Streamline TL Spinal SystemPioneer Surgical Technology, Inc.201189—
+4K101790Quantum Spinal System, Quantum MisPioneer Surgical Technology201110—
+4K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+4K100297Pass LP Spinal SystemMedicrea Technologies2010136—
+4K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+4K081296Preference Pedicle Screw SystemUs Spine20083—
+5K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+5K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+5K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+5K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+5K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+5K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+5K131100Streamline TL Spinal SystemPioneer Surgical Technology, Inc.20136—
+5K123552Instinct Java SystemZimmer Spine201301
+5K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+5K112493Pass LP Spinal SystemMedicrea International20111—
+5K110497Pass LP Spinal SystemMedicrea International20111331
+5K111502Streamline TL Spinal SystemPioneer Surgical Technology, Inc.201188—
+5K081883Modification to Preference Pedicle Screw SystemUs Spine20082—
+6K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+6K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+6K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+6K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+6K153413PASS LP Spinal SystemMedicrea International SA20160—
+6K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+6K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine201482—
+6K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+6K123138Pass LP Spinal SystemMedicrea International2013132—
+7K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+7K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+7K182721Choice Spine Navigation SystemChoicespine, LP20192—
+7K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+7K170942The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP20170—
+7K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP201673—
+7K150380ProMIS Fixation SystemPremia Spine, Ltd.20154—
+7K142798PASS LP Spinal SystemMedicrea International SA201584—
+7K150049PASS LP Spinal SystemMedicrea International20150—
+7K141398Pass LP Spinal SystemMedicrea International SA2015101
+7K140738Pass LP Spinal SystemMedicrea International201447—
+7K132574Pass LP Spinal SystemMedicrea International20130—
+7K132575Pass LP Spinal SystemMedicrea International20130—
+8K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+8K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K231844ProMIS™ Fixation SystemPremia Spine, Ltd.20231—
+8K211981KHEIRON® Spinal Fixation SystemS.M.A.I.O20228—
+8K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+8K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+8K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+8K202771CD Horizon Spinal SystemMedtronic202021—
+8K182598VersaLink™ Fixation SystemPremia Spine, Ltd.20180—
+8K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+8K180376K2M Patient Specific RodsK2m, Inc.20182—
+8K170061ProMIS™ Fixation SystemPremia Spine, Ltd.20170—
+8K160640PASS XS Spinal SystemMedicrea International SA20160—
+8K161627PASS LP Spinal SystemMedicrea International SA20167—
+8K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+9K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+9K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+9K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+9K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+9K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+9K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+9K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+9K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+9K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+9K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+9K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+9K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+9K211323ASTRA Spine SystemSpinecraft, LLC202112—
+9K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+9K210306GII Spinal Fixation SystemColigne AG20210—
+9K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+9K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+9K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+9K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+9K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+9K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+9K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+9K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+9K162786PASS LP Spinal SystemMedicrea International SA20176—
+9K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+10K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+10K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+10K261374LigaPASS™ SystemMedicrea International S.A.S20260—